Low-Dose Mifepristone in Fibroid Management: A Single-Center Prospective Study in Goa, India
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- symptom relief
研究概览
简要总结
This study aims to evaluate the efficacy and safety of low-dose mifepristone in managing symptomatic uterine fibroids in women of reproductive age. Uterine fibroids, common benign tumors, can cause significant symptoms like heavy bleeding, pain, and reproductive issues, traditionally managed through surgery or pharmacological treatments. Mifepristone, a progesterone receptor modulator, has shown promise in reducing fibroid size and alleviating symptoms with fewer side effects than traditional treatments. The study, conducted at Healthway Hospitals in Goa, India, will focus on women aged 18–49 with fibroids sized between 3-8 cm, assessing changes in fibroid size, symptom relief, and adverse effects. Results from similar studies suggest mifepristone can significantly reduce fibroid size, improve hemoglobin levels, and relieve menstrual bleeding and pain with minimal side effects, offering a potential non-surgical treatment option for symptomatic fibroids. The study will employ a prospective, observational design over two years, with data analyzed for descriptive statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •Females of reproductive age group 18 to 49 years with symptomatic fibroids sized more than 3cm and less than 8cm Women with Pictorial Blood Loss Assessment Chart PBAC more than 100 Women diagnosed with uterine fibroid.
排除标准
- •Women allergic to mifepristone Pregnant or lactating mothers Women with a history of DVT/thromboembolism, liver dysfunction Those not consenting to be a part of the study.
结局指标
主要结局
symptom relief
时间窗: symptom relief 2 years | menstrual changes PBAC 2 years
menstrual changes PBAC
时间窗: symptom relief 2 years | menstrual changes PBAC 2 years
次要结局
- NA(NA)
研究者
Dr Rini Naik
Healthway Hospitals Pvt. Ltd.,
